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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010200
Device Problem Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Date 09/04/2019
Event Type  malfunction  
Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product will not be returned to zimmer biomet.Product is being evaluated by external contractor.Once the investigation is complete, a follow up/final report will be submitted.
 
Event Description
It was reported that the unit had a burning smell, and the touch screen was not responsive.The event timing was before surgery.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The previous repair record for intellicart system serial number 1160060 was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 4 times, the previous repair being for vacuum sensor errors on 29 august 2019.The vacuum pump is not associated with the current repair.Thus, this repair was a non-related issue.On 4 september 2019, it was reported from (b)(6) hospital that the unit had a burning smell and the touch screen was not responsive.On 4 september 2019, a zimmer biomet certified service repair technician was contacted about the cart and was dispatched to be at the site.On 5 september 2019, the technician arrived at the site, evaluated the device, and was unable to duplicate a concern regarding the monitor; however, he confirmed a smell like hot plastic emanating from the unit.He replaced the vacuum pump.The unit was run continuously but the smell persisted.On 12 september 2019, the technician replaced the control board and power supply but noted no improvement.The technician was unable to find any issues and had an exchange unit prepared.A new cart (serial #1590162) was shipped from riverside on 12 september 2019, and the replacement cart was noted to be delivered on 16 september 2019.A service technician was dispatched to the site to perform the exchange.On 23 september 2019, the service technician confirmed that the exchange was completed and that the exchanged unit was packaged and ready for return.The exchange cart was picked up from the facility on 23 september 2019 and was confirmed that it was returned to riverside on 27 september 2019.The cart was refurbished as noted in crm with new serial number #(b)(4).Service work order (b)(4) on 4 september 2019.The reported event of the touch screen not responding could not be confirmed and the reported event for an odor from the unit was confirmed during inspection of the device; however, the root cause could not be determined and the device was replaced and refurbished as a result.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.
 
Event Description
No additional event information.
 
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Brand Name
DUO FLUID CART WITH SMOKE EVACUATOR
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
DORNOCH
200 northwest parkway
riverside MO 64150
MDR Report Key9079130
MDR Text Key199709625
Report Number0001954182-2019-00058
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
PMA/PMN Number
K162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00514010200
Device Lot Number0023808
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/04/2019
Initial Date FDA Received09/17/2019
Supplement Dates Manufacturer Received09/04/2019
Supplement Dates FDA Received10/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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